Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
20 Years
40 Years
Female
BRCA1 Mutation, Breast Cancer
Trial Information
Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
OBJECTIVES:
Primary
- Determine whether the genomic profiles of breast epithelial cells of high-breast
cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition,
express a signature indicative of high-risk.
Secondary
- Determine whether women identified to express a "high-breast cancer-risk" signature
will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which
should have induced breast differentiation and genomic changes that would serve as
biomarkers indicative of decreased breast cancer risk.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three
times weekly. Treatment continues weekly for 90 days in the absence of unacceptable
toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and
day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67
immunohistochemical staining for cell proliferation, cDNA microarray for gene expression,
and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Asymptomatic women who have a deleterious mutation on the BRCA1 gene
- Normal, no complaints, no evidence of disease
- Nulliparous, never pregnant (G0P0)
- No previous diagnosis of breast or ovarian cancer
- No known brain metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100%
- Premenopausal with normal menstrual cycles and intact ovaries
- Normal ovarian size report from pelvic ultrasound
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to human chorionic gonadotropin preparations or one of its
excipients
- No uncontrolled intercurrent illness including any of the following:
- Ovarian enlargement of undetermined origin
- Ovarian cysts > 2 cm
- Microcystic ovaries, which might predispose to the development of ovarian
hyperstimulation syndrome
- History of prior cancer other than non-melanoma skin cancer
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Severe cognitive deficit or psychiatric illness/social situations that would
make her unable to give informed consent or would limit compliance with study
requirements
PRIOR CONCURRENT THERAPY:
- At least 6 weeks since prior and no concurrent oral contraceptives or
hormone-replacement therapy
- No concurrent tamoxifen for chemoprevention
- No concurrent participation in another chemopreventive trial for breast cancer
- No concurrent medication that could interfere with this study including any of the
following:
- Hormonal contraceptives
- Androgens
- Prednisone
- Thyroid hormones
- Insulin
- No other concurrent investigational agents
- No recent treatment with follicle-stimulating hormone for assisted reproduction
- No HIV-positive patients on concurrent combination antiretroviral therapy
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Measurement of gene expression in breast epithelial cells obtained for asymptomatic high breast cancer risk nulliparous premenopausal women at baseline, after treatment with r-hCG at 90 days, and at 270 days from baseline
Outcome Time Frame:
90 days and 270 days from baseline
Safety Issue:
No
Principal Investigator
Jose Russo, MD, FCAP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
06827
NCT ID:
NCT00700778
Start Date:
July 2008
Completion Date:
Related Keywords:
- BRCA1 Mutation
- Breast Cancer
- breast cancer
- BRCA1 mutation carrier
- Breast Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
